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The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test formula | Experimental | Partially hydrolyzed formula with synbiotics |
|
| Control formula | Active Comparator | Intact protein formula without synbiotics |
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| Reference arm | No Intervention | Breastfed arm (not applicable for France) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formula | Other | Partially hydrolyzed formula with synbiotics |
| |
| Measure | Description | Time Frame |
|---|---|---|
| TransEpidermal Water Loss (TEWL) at 3 months | TransEpidermal water loss will be measured using a validated non-invasive technique. | At 3 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of Atopic Dermatitis | Cumulative incidence of AD is based on physician diagnosis using the United Kingdom Working Party (UKWP) diagnosis criteria. | From enrollment to 12 months of age |
| TransEpidermal Water Loss |
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Inclusion Criteria:
Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
Infant gestational age ≥ 37 completed weeks
Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.
or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.
Parents/LAR must be able to provide evidence of parental authority and identity.
Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelie Goyer, PhD | Contact | +41217858939 | Amelie.Goyer1@rd.nestle.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan | Recruiting | Bruges | Belgium |
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| Control formula |
| Other |
Intact protein formula without synbiotics |
|
Epidermal water loss will be measured using a validated non-invasive technique.
| From enrollment to 12 months of age |
| Skin surface (stratum corneum) hydration | Skin hydration will be measured with a corneometer device. | From enrollment to 12 months of age |
| Extent and severity of Atopic Dermatitis | SCORAD (SCORing for Atopic Dermatitis), scores range from 0 to 103, with higher scores indicating higher atopic dermatitis severity | From 3 months to 12 months of age |
| Cumulative use of topical steroids and calcineurin inhibitors | Use of medication to treat AD and other symptoms will be collected via parent self-reported questionnaire. | From enrollment to 12 months of age |
| Skin cytokines | Concentration of skin cytokines such as IL4 and IL5 using immunoassays | From enrollment to 12 months of age |
| Skin natural moisturizing factors | Concentration of skin natural moisturizing factors such as Pyrrolidone carboxylic acid, using HPLC | From enrollment to 12 months of age |
| Skin stratum corneum lipids | Concentration of skin stratum corneum lipids such as ceramides, cholesterol and triacylglycerol using mass spectrometry | From enrollment to 12 months of age |
| Skin microbiome | Overall skin microbiome composition and diversity using next-generation sequencing | From enrollment to 12 months of age |
| Skin metabolites | Levels of skin metabolites using targeted or untargeted approaches. | From enrollment to 12 months of age |
| Immune proteomics | Levels of plasma proteins using mass cytometry or immunoassaysand immunoassays. | From enrollment to 6 months of age |
| Immune blood cell immunophenotyping | Levels of immune cell populations using mass cytometry or immunoassays | From enrollment to 6 months of age |
| Specific IgE antibodies | Specific IgE antibodies will be measured using Phadiatop infant®. | At 12 months of age |
| Fecal microbiome | Overall fecal microbiota composition, diversity, different bacteria taxa and microbiota community types assessed using next generation sequencing (NGS) technology | From enrollment to 12 months of age |
| Fecal metabolites | Levels of fecal metabolites using targeted or untargeted approaches. | From enrollment to 12 months of age |
| Fecal biomarkers of inflammation and immunity | Levels of fecal markers of immune health and inflammation such as total secretory IgA (sIgA), calprotectin, and α-1-antitrypsin assessed by ELISA. | From enrollment to 12 months of age |
| Physician-diagnosed allergic manifestations | Number of participants with Physician-diagnosed allergic manifestations. | From enrollment to 12 months of age |
| Gastrointestinal tolerance | Infant Gastrointestinal Symptom Questionnaire (IGSQ), scores range from 13 to 65, with higher scores indicating higher gastrointestinal discomfort. | At enrollment and 4 months of age |
| Weight | Weight (g and z-scores) | From enrollment to 12 months of age |
| Height | Length (cm and z-scores) | From enrollment to 12 months of age |
| Head circumference | Head circumference (cm and z-scores) | From enrollment to 12 months of age |
| Safety assessment | Incidence of adverse events | From enrollment to 13 months of age |
| Universitair Ziekenhuis Brussel - Kinderziekenhuis | Recruiting | Brussels | Belgium |
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| Clinique Ste Elisabeth | Recruiting | Namur | Belgium |
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| CHU Amiens Picardie | Recruiting | Amiens | France |
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| CHU de Caen | Recruiting | Caen | France |
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| CHU de Grenoble Alpes | Recruiting | Grenoble | France |
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| Hôpital de la Croix Rousse | Recruiting | Lyon | France |
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| Hôpital Charles Nicolle | Recruiting | Rouen | France |
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| CHRU de Tours | Recruiting | Tours | France |
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| Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) | Not yet recruiting | Berlin | Germany |
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| Evangelisches Krankenhaus Düsseldorf - Frauenklinik | Recruiting | Düsseldorf | Germany |
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| Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt | Recruiting | Frankfurt | Germany |
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| Evangelisches Waldkrankenhaus Spandau | Recruiting | Spandau | Germany |
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| Marien Hospital Wesel GmbH | Not yet recruiting | Wesel | Germany |
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| Hospital Teresa Herrera | Recruiting | A Coruña | Spain |
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| HU Torrecárdenas | Recruiting | Almería | Spain |
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| Hospital Quiron Salud Barcelona | Recruiting | Barcelona | Spain |
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| Hospital Universitario Severo Ochoa | Recruiting | Madrid | Spain |
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| Grupo Pediátrico Uncibay | Recruiting | Málaga | Spain |
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| Instituto Hispalense de Pediatria (IHP) | Recruiting | Seville | Spain |
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| Hospital Universitari de Tarragona Joan XXIII | Recruiting | Tarragona | Spain |
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| Hospital Universitari Sant Joan de Reus | Recruiting | Tarragona | Spain |
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| HCU Lozano Blesa | Recruiting | Zaragoza | Spain |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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